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[摘要]
人胰岛素Afrezza粉雾剂是由MannKind公司研发上市的速效吸入型胰岛素,即Technosphere胰岛素(TI),是药物和第二代吸入器的组合产品。人胰岛素粉雾剂是一种有效及耐受良好的降糖药物,用于1型糖尿病(T1DM)和2型糖尿病(T2DM)患者餐前给药降糖,提供了一种解决胰岛素初始治疗时诸如注射恐惧症、担忧体质量增加和低血糖风险的替代疗法。吸入TI的降糖疗效虽然低于皮下注射,但是低血糖和体质量增加的发生率更低,其长期疗效和安全性需要进一步深入研究。探讨了吸入TI粉雾剂的原理、药理作用、治疗T1DM和T2DM的临床疗效、安全性和耐受性等内容。
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[Abstract]
Afrezza (human insulin) inhalation powder developed by MannKind Corporation is a drug and device combination product consisting of Technosphere insulin (TI) and an oral inhaler device (the Gen2 inhaler). Inhaled TI is an effective and generally well-tolerated agent for the prandial treatment of hyperglycaemia in T1DM and T2DM patients and may provide a solution to insulin initiation barriers such as injection phobia, which concerns of bodyweight gain and hypoglycaemia. Glycaemic efficacy of TI is lower than that of sc insulin, but inhaled insulin has a lower risk of severe hypoglycaemia and weight gain. Long-term outcomes and safety with TI should be further investigated. This review discusses the rationale for pulmonary delivery of insulin, pharmacological, efficacy, safety, and tolerability data relevant to the use of TI in T1DM and T2DM.
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